We partner with biotech and pharmaceutical companies to deliver high-quality statistical design, analysis, and regulatory-ready outputs — efficiently and cost-effectively.
Unlike large CROs with layered structures, we operate with a lean, expert-led model — ensuring faster turnaround, direct communication, and lower cost without sacrificing quality.
No junior outsourcing. Every project is led by experienced biostatisticians who bring deep regulatory knowledge directly to your team. You always know who is working on your program.
All outputs are built to meet FDA, EMA, and global submission standards from the start — not retrofitted. We understand what reviewers expect and design every deliverable accordingly.
From ad hoc statistical support to full study ownership, our engagement model adapts to your program's stage and budget. Scope exactly what you need — no rigid structures, no minimums.
Our lean structure means less overhead and more value per dollar — without cutting corners on rigor. High-quality biostatistics doesn't have to come with a large-CRO price tag.
From first-in-human through NDA submission, we cover the full statistical lifecycle of clinical development.
Rigorous statistical design and analysis across all development phases, with direct senior oversight at every step.
eCTD-ready datasets, TLFs, and submission packages built to CDISC standards in SAS, R, or Python.
Submission support, ISS/ISE development, and reviewer response assistance to carry your program across the finish line.
Interim reviews, Bayesian methods, real-world evidence, and machine learning-assisted exploratory analysis.
Strategic protocol development and endpoint selection optimized for regulatory success and operational feasibility.
High-level strategic partnership for programs that need experienced biostatistical thinking early and often.
A clear, collaborative process from first conversation to final delivery.
Understand your program goals, timeline, and regulatory context
Detailed scoping of statistical tasks, deliverables, and responsibilities
Transparent proposal with clear milestones and fixed or flexible pricing
Senior-led execution with direct communication throughout
Independent validation and thorough QC before every deliverable
Continued support through review cycles, queries, and subsequent submissions
We adapt to where you are in development and what you need — not the other way around.
Defined scope, clear timeline, fixed deliverables. Ideal for discrete statistical tasks or a single study phase.
A dedicated senior statistician or programmer embedded in your team on a monthly basis — with full-team backup.
Long-term, deeply embedded collaboration across your entire clinical development program — from IND through NDA.
Every deliverable is built to the exacting standards required for global regulatory submissions.
All statistical analysis plans and methodology align with ICH E9 guidance, including the E9(R1) addendum on estimands.
All datasets conform to CDISC standards for electronic submission, including full reviewer's guide documentation.
Secure environments with controlled access, audit trails, and electronic records management in full compliance with 21 CFR Part 11.
Every output passes through multiple independent validation layers before delivery — no exceptions.
From early-stage biotech to established pharma, we tailor our approach to the unique needs of each client and study type.
IND-enabling studies, protocol design, and regulatory strategy for companies with lean internal teams
Phase II/III trial support and submission packages for established programs seeking flexible specialist capacity
Rigorous study design and statistical analysis for investigator-initiated and academic-sponsored research
Device-specific statistical methodology and regulatory submission support aligned with FDA and global standards
From study start-up through reporting, all discussions on statistical strategy and best practice were conducted with a clear understanding of the sponsor's objectives for the trial.
Let's accelerate your clinical program with precision. Our team is ready to discuss your statistical needs — whether you're designing a first-in-human study or preparing for your NDA submission.